# FDA 483 - U.S. Navy Medicine Readiness and Training Command Naples Italy - April 15, 2025

Source: https://www.keypedia.com/records/483/us-navy-medicine-readiness-and-training-command-naples-italy/a90dfa44-e5d0-4a3c-a06e-66706b959c12

> FDA 483 for U.S. Navy Medicine Readiness and Training Command Naples Italy on April 15, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: U.S. Navy Medicine Readiness and Training Command Naples Italy
- Inspection Date: 2025-04-15
- Product Type: biologics
- Office Name: Division of Blood Components and Devices
- Summary: An FDA inspection of the Department of Defense - Navy (U.S. Naval Hospital Naples) identified significant deficiencies in record-keeping practices. Observations included incomplete processing records for red blood cell deglycerolization and inadequate documentation for centrifuge maintenance used in compatibility testing. These issues indicate a failure to maintain detailed records necessary for a complete history of work performed.

## Related Documents

- [483 - 2025-04-15](https://www.keypedia.com/records/483/us-navy-medicine-readiness-and-training-command-naples-italy/0b817249-806e-407d-a1f7-0e4ddbff60a1)

## Related Officers

- [Lesley Mae P. Lutao](https://www.keypedia.com/people/lesley-mae-p-lutao/bfdcc755-28e5-4caf-91f9-b9579df4731e)

Company: https://www.keypedia.com/companies/us-navy-medicine-readiness-and-training-command-naples-italy/dac6a5df-9ea5-4c9b-97ab-8e8116229d33

Office: https://www.keypedia.com/offices/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917